Recalls / —
—#123232
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
- FDA product code
- ILO — Pack, Hot Or Cold, Water Circulating
- Device class
- Class 2
- Medical specialty
- Physical Medicine
- Affected lot / code info
- Lot Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413
Why it was recalled
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Root cause (FDA determination)
Device Design
Action the firm took
DeRoyal sent a "URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.
Recalling firm
- Firm
- DeRoyal Industries Inc
- Address
- 1595 Highway 33 S, New Tazewell, Tennessee 37825-7105
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2013-09-17
- Posted by FDA
- 2014-01-27
- Terminated
- 2017-06-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #123232. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.